On February 27, 2018, Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force (PIL Task Force), which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors. This is the latest development in the government’s increasing focus over the past year on the opioid epidemic.
The DOJ announcement cites the substantial costs to the government caused by the opioid crisis and states that the PIL Task Force will use Drug Enforcement Administration rules and the False Claims Act against pain-management clinics, drug testing facilities, and individual physicians who prescribe opioids. The PIL Task Force also will expand the efforts of the DOJ’s Opioid Fraud and Abuse Detection Unit (the Unit), created in August 2017. The Unit includes twelve Assistant United States Attorneys, whose sole focus is to investigate and prosecute fraud related to opioids. The Unit uses data analytics to identify physicians that prescribe opioids at far higher rates than their peers, physicians with high numbers of patient deaths within 60 days of an opioid prescription, and pharmacies that dispense disproportionately large amounts of opioids.
The PIL Task Force also will determine what, if any, assistance it can provide to the many existing state and local government lawsuits against drug manufacturers that seek to hold the drug manufacturers responsible for the nation’s increasing levels of opioid abuse. Generally, these suits center around allegations that manufacturers have engaged in deceptive marketing practices by downplaying the risk of opioid addiction, over-stating the efficacy of opioids, and persuading prescribers to prescribe opioids to a broader range of patients beyond just patients with short-term acute pain or terminal illnesses. Moreover, some of the suits allege that manufacturers have funded and assisted seemingly-neutral third parties, such as physicians and patient advocacy groups, to influence guidance distributed in treatment guidelines, medical seminars, and scientific articles. The causes of action asserted generally are based on (1) violations of state consumer protection or corrupt practices laws; (2) violations of state false claims acts; (3) public nuisance; and (4) equitable theories, such as fraud and unjust enrichment.
In a separate announcement, the DOJ also stated that it will file a statement of interest in a multi-district action regarding hundreds of lawsuits by cities, municipalities, and medical institutions against drug manufacturers and distributors. The federal, state, and local governments’ increasing focus on drug manufacturers makes it imperative for manufacturers of opioids and similar pain control products to adequately train their sales forces on messaging related to such products, and to develop appropriate marketing and sales practices aimed at limiting prescribing to the on-label use of such products. As described above, the DOJ and US Attorney General offices in multiple states, as well as local and state governments, are aggressively investigating and litigating this issue. Therefore, drug manufacturers and distributors should be on the lookout for government subpoenas or other communications from the PIL Task Force or other government authorities and seek skilled counsel at the earliest opportunity.